21 CFR 864.3800 — Stainer, Tissue, Automated
Pathology (PA) · Part 864 Subpart D—Pathology Instrumentation and Accessories · § 864.3800
Identification
An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis.
Classification Rationale
Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KEY | Stainer, Tissue, Automated | 1 | 1 | |
| KIN | Slide Stainer, Contact Type | 1 | 1 | |
| KIO | Slide Stainer, Immersion Type | 1 | 1 | |
| KPA | Slide Stainer, Automated | 1 | 21 |
